Skip to main content
OpenTrials
Completed

NCT Number: NCT00766844

Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).

It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois Medical Center in Chicago

Chicago, Illinois, 60612, United States

About this study

Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm.

The patients are followed for 12 months after completion of stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65
  • Subarachnoid hemorrhage (SAH) within 72 hours
  • Ruptured aneurysm confirmed by angiography of CT angiography
  • Fisher grade 2-4
  • Hunt & Hess grade 2-4
  • Aneurysm is secured
  • Ability to obtain informed consent

Exclusion criteria

  • Pregnancy
  • Allergy to IV contrast or to any component of SCS system
  • Non-aneurysmal SAH
  • Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
  • Coagulopathy

Treatment and study plan

Spinal Cord Stimulation

Device

electrode is inserted into cervical epidural space for continuous spinal cord stimulation

Primary outcomes

  1. Prevention of cerebral vasospasm

    Time frame: 14-17 days after aSAH

Secondary outcomes

  1. Any complication of spinal cord stimulation

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Konstantin V. Slavin

Other

Registry information

Official study title

Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 6, 2008
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.